Bubble Leak Testing Explained | ASTM F2096

How to Perform a Bubble Leak Test

Used to detect gross leaks in packaging, bubble leak testing is a highly accurate testing method used throughout the medical packaging industry. It is particularly useful for checking the integrity of packaging and pouches that need to provide a sterile environment for their contents.
Not sure if it should be part of your testing process or wondering which quality assurance standards it refers to? Dive in for everything you need to know about bubble leak tests and the standard pressurized bubble testing method, ASTM F2096.

What is a bubble leak test?

A bubble leak test is cost effective way to determine whether packaging or equipment has a leak. It plays a crucial role in the testing of health care equipment and sealed packages, as it allows manufacturers and buyers to find out whether the contents of the product remain protected from the outside environment.

Bubble leak testing and ASTM F2096

Bubble leak testing is often referred to as ASTM F2096, the official title for a certain kind of bubble test, and it is accepted as a standard testing method for detecting leaks in packaging using internalized pressure. It is also known as a submersion leak test, bubble emission test or underwater immersion leak test.
ASTM F2096 is a standard set by ASTM International, a globally recognized leader in the development and delivery of voluntary consensus standards for a wide range of industries.

How to carry out bubble leak testing

An ASTM F2096 test submerges a packet or pouch under at least one inch of water. A low pressure is supplied to the packaging in a controlled flow and the packaging is closely monitored for any signs of escaping air. A continuous flow of bubbles indicates a leak and shows that any sterile barriers have been breached.

Units of measurement used in ASTM F2096 testing

To comply with standards, a bubble leak test must be able to detect leaks from holes of 250 μm (0.010 in.) or 250-microns.

Bubble leak testing equipment

Not all bubble leak testing equipment is created to comply with ATSM standards. To make sure that medical grade packaging and equipment is fully compliant, it’s necessary to choose testers that offer low pressure, controlled flow, and high sensitivity sensors..
One popular option is the TME Pressure Bubble Tester, which delivers a low-pressure control range of 0 to 2 psig with stable flow, thanks to its precision pressure regulator. It is suitable for testing both porous material packages and non-porous pouches.

Advice for incorporating or adjusting your bubble leak testing solution

Decades of experience in medical packaging testing means that the Industrial Physics team is perfectly placed to help packaging manufactures and labs of all sizes as they ensure their products are compliant with internationally recognized safety regulations.
For specialist advice in choosing, integrating, or implementing a new testing solution for your medical packaging and devices, get in touch.